Prenate Pixie: Package Insert / Prescribing Info

Rx Only Dietary Supplement

DESCRIPTION:PRENATE PIXIE ®is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is purple in color, opaque, and imprinted with “PIX”. Prenate Pixie ®contains no ingredient made from gluten-containing grain (wheat, barley, or rye)

INDICATIONS:PRENATE PIXIE ®is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.

CONTRAINDICATIONS:PRENATE PIXIE ®is contraindicated in patients with a known hypersensitivity to any of the ingredients.

PRECAUTIONS:Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

Biotin levels higher than the recommended daily allowance may cause interference with some laboratory tests, including cardiovascular diagnostic test (e.g. troponin) and hormone tests, and may lead to incorrect test results. Tell your healthcare provider about all prescription and over-the-counter medicines, vitamins, and dietary supplements that you take, including biotin.

ADVERSE REACTIONS:Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

DOSAGE AND ADMINISTRATION:Before, during and/or after pregnancy, one softgel daily or as directed by a physician.

HOW SUPPLIED:Bottles of 30 softgels (75854-0316-30). The listed product number is not a National Drug Code. Instead, Avion Pharmaceuticals has assigned a product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems.

STORAGE:Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]

THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Sumalate® is a registered trademark of Albion Laboratories, Inc., covered by one or more claims of U.S. Patent Nos. 5,516,925, 6,716,814, 8,007,846, and 8,425,956.

MANUFACTURED FOR:

Avion Pharmaceuticals, LLC
Alpharetta, Georgia 30005

1-888-61-AVION

L-0244 Rev. 0325-03

75854-0316-30

Prenate pixie®

Robust Rx Prenatal Vitamin with
11 concentrated nutrients and minerals

in a tiny softgel package

SUGAR FREE

GLUTEN FREE

LACTOSE FREE

Rx Only

Dietary Supplement

30 Softgels